Bio-Process Engineer

HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career.
How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do.
It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide.
Come do your best work alongside other innovative, driven professionals in this meaningful role.
Bio-Process Engineer Live What you will do Let’s do this.
Let’s change the world.
In this role support manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO).
The engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and lead all aspects of the operation and reliability of equipment while driving safety and quality compliance.
The engineer will support the department and capital projects and provide data to support business cases and long term strategy.
The Engineer role will provide direct engineering technical support as follows: Model leadership behaviors and positive values to create a positive working environment.
Be individually accountable for the consistent equipment performance Be accountable for assigned results on key capital projects Suggest design modifications to address risks and design in quality and safety.
Provide oversight for verification work developed by outsourced/contract verification staff.
Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety practices.
Ensure safety during commissioning, validation, maintenance, and manufacturing activities Related Activities: Participate or lead, when required, multidisciplinary site teams, e.
g.
Multi-functional Team, Root Cause Analysis lead.
Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
Provide ad hoc technical support and guidance for manufacturing and maintenance Mentor and guidance to project teams and engineers using risk-based approaches Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections Participate in internal audits and assess in conjunction with quality assurance Assist in developing and maintaining business metric performance Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.
The engineering professional we seek will possess these qualifications.
Basic Qualifications: Master’s degree OR Bachelor’s degree & 2 years of engineering and/or manufacturing experience Or Associate’s degree & 6 years of engineering and/or manufacturing experience Or High school diploma / GED & 8 years of engineering and/or manufacturing experience Preferred Qualifications: Bachelor's degree in engineering or another science-related field 7+ years of relevant work experience with 5+ years’ experience in operations/manufacturing environment Direct experience with regulated environments (FDA, OSHA, EPA, etc.
) Knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution Experience with combination product / medical device quality systems verification Process equipment knowledge – basic principles of cell culture, fermentation, purification, filling Process automation knowledge – fundamental understanding of automation infrastructure Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus Strong communication and technical writing skills Strengths in facilitation and collaboration / networking Experience in developing SOPs and delivering training Individual must be a standout colleague prepared to work in and embrace a team-based environment that relies on collaboration for effective decision-making Basic understanding of process improvement methodologies to mature and improve business performance (examples: PDCA, LEAN, Six Sigma, etc.
) Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear.
Join us.
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amgen.
com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.